FDA.reportPublic FDA data

VARENICLINE

Product NDC
72162-2219
11-digit product format
721622219
Labeler code
72162
Product ID
72162-2219_a2386f55-4425-4caf-9b74-af9f5a80c2f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARENICLINE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA201962
Marketing category
ANDA
Marketing start
2023-01-30
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VARENICLINE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636676

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72162-2219-2VARENICLINE56 in 1 BOTTLETABLET, FILM COATED56102
72162-2219-3VARENICLINE30 in 1 BOTTLETABLET, FILM COATED30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2219-2EA - Each72162-22198bb711e8-80c9-4656-b697-f84237cc6cc612024-02-14
72162-2219-3EA - Each72162-2219c1b04b8b-4453-4224-92c5-6030407bef6c12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2219VARENICLINE TABLET, FILM COATED [BRYANT RANCH PREPACK]102Current NDC, 2 package rows20240718_dc0d2c60-b197-4bbf-a3fd-78e0f5a21440.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
636676varenicline 1 MG Oral TabletPSNdc0d2c60-b197-4bbf-a3fd-78e0f5a21440102
636676varenicline 1 MG Oral TabletSCDdc0d2c60-b197-4bbf-a3fd-78e0f5a21440102
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYdc0d2c60-b197-4bbf-a3fd-78e0f5a21440102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72162-2219-27216222190256 TABLET, FILM COATED in 1 BOTTLE (72162-2219-2) 2024-01-05NoNoHistorical
72162-2219-37216222190330 TABLET, FILM COATED in 1 BOTTLE (72162-2219-3) 2024-01-05NoNoHistorical